E7-16730. Controlled Substances: Final Revised Aggregate Production Quotas for 2007

AGENCY:

Drug Enforcement Administration (DEA), Justice.

ACTION:

Notice of final aggregate production quotas for 2007.

SUMMARY:

This notice establishes final 2007 aggregate production quotas for controlled substances in schedules I and II of the Controlled Substances Act (CSA). The DEA has taken into consideration comments received in response to a notice of the proposed revised aggregate production quotas for 2007 published May 3, 2007 (72 FR 24608).

EFFECTIVE DATE:

August 24, 2007.

FOR FURTHER INFORMATION CONTACT:

Christine A. Sannerud, PhD, Chief, Drug and Chemical Evaluation Section, Drug Enforcement Administration, Washington, DC 20537, Telephone: [phone].

SUPPLEMENTARY INFORMATION:

Section 306 of the CSA (21 U.S.C. 826) requires that the Attorney General establish aggregate production quotas for each basic class of controlled substance listed in schedules I and II. This responsibility has been delegated to the Administrator of the DEA by 28 CFR 0.100. The Administrator, in turn, has redelegated this function to the Deputy Administrator, pursuant to 28 CFR 0.104.

The 2007 aggregate production quotas represent those quantities of controlled substances in schedules I and II that may be produced in the United States in 2007 to provide adequate supplies of each substance for: the estimated medical, scientific, research and industrial needs of the United States; lawful export requirements; and the establishment and maintenance of reserve stocks (21 U.S.C. 826(a) and 21 CFR 1303.11). These quotas do not include imports of controlled substances.

On May 3, 2007, a notice of the proposed revised 2007 aggregate production quotas for certain controlled substances in schedules I and II was published in the Federal Register (72 FR 24608). All interested persons were invited to comment on or object to these proposed aggregate production quotas on or before May 24, 2007.

Nine companies commented on a total of 31 schedules I and II controlled substances within the published comment period. Nine companies proposed that the aggregate production quotas for 14-hydroxymorphinone, alfentanil, amphetamine (for sale), amphetamine (for conversion), cocaine, codeine (for conversion), dextropropoxyphene, dihydromorphine, diphenoxylate, ecgonine, fentanyl, gamma hydroxybutyric acid, hydrocodone, hydromorphone, lisdexamfetamine, meperidine, methadone, methadone intermediate, methylphenidate, morphine, morphine (for conversion), nabilone, noroxymorphone (for conversion), oxycodone, oxymorphone, oxymorphone (for conversion), pentobarbital, remifentanil, sufentanil, tetrahydrocannabinols, and thebaine were insufficient to provide for the estimated medical, scientific, research, and industrial needs of the United States, for export requirements and for the establishment and maintenance of reserve stocks.

The DEA has determined that the compound 14-hydroxymorphinone is a morphine derivative. The comment received concerning this substance was therefore, considered as a comment for morphine.

DEA has taken into consideration the above comments along with the relevant 2006 year-end inventories, initial 2007 manufacturing quotas, 2007 export requirements, actual and projected 2007 sales, research, product development requirements and additional applications received. Based on this information, the DEA has adjusted the final 2007 aggregate production quotas for 2,5-dimethoxyamphetamine, alfentanil, amphetamine (for conversion), gamma-hydroxybutyric acid, hydrocodone, methylphenidate, oxycodone, oxycodone (for conversion), pentobarbital, remifentanil, sufentanil and thebaine to meet the legitimate needs of the United States.

Regarding amphetamine (for sale), cocaine, codeine (for conversion), dextropropoxyphene, dihydromorphine, diphenoxylate, ecgonine, fentanyl, hydromorphone, lisdexamfetamine, meperidine, methadone, methadone intermediate, morphine, morphine (for conversion), nabilone, noroxymorphone (for conversion), oxymorphone, oxymorphone (for conversion), and tetrahydrocannabinols the DEA has determined that the proposed revised 2007 aggregate production quotas are sufficient to meet the current 2007 estimated medical, scientific, research, and industrial needs of the United States and to provide for adequate inventories.

Therefore, under the authority vested in the Attorney General by section 306 of the CSA (21 U.S.C. 826), and delegated to the Administrator of the DEA by 28 CFR 0.100, and redelegated to the Deputy Administrator, pursuant to 28 CFR 0.104, the Deputy Administrator hereby orders that the 2007 final aggregate production quotas for the following controlled substances, expressed in grams of anhydrous acid or base, be established as follows:

Basic class—Schedule I	Final revised 2007 quotas (grams)
2,5-Dimethoxyamphetamine	2
2,5-Dimethoxy-4-ethylamphetamine (DOET)	2
2,5-Dimethoxy-4-(n)-propylthiophenethylamine (2C-T-7)	10
3-Methylfentanyl	2
3-Methylthiofentanyl	2
3,4-Methylenedioxyamphetamine (MDA)	20
3,4-Methylenedioxy-N-ethylamphetamine (MDEA)	10
3,4-Methylenedioxymethamphetamine (MDMA)	22
3,4,5-Trimethoxyamphetamine	2
4-Bromo-2,5-dimethoxyamphetamine (DOB)	2
4-Bromo-2,5-dimethoxyphenethylamine (2-CB)	7
4-Methoxyamphetamine	77
4-Methylaminorex	2
4-Methyl-2,5-dimethoxyamphetamine (DOM)	12
5-Methoxy-3,4-methylenedioxyamphetamine	2
5-Methoxy-N,N-diisopropyltryptamine	5
Acetyl-alpha-methylfentanyl	2
Acetyldihydrocodeine	2
Acetylmethadol	2
Allylprodine	2
Alphacetylmethadol	2
Alpha-ethyltryptamine	2
Alphameprodine	2
Alphamethadol	3
Alpha-methylfentanyl	2
Alpha-methylthiofentanyl	2
Alpha-methyltryptamine	5
Aminorex	8
Benzylmorphine	2
Betacetylmethadol	2
Beta-hydroxy-3-methylfentanyl	2
Beta-hydroxyfentanyl	2
Betameprodine	2
Betamethadol	2
Betaprodine	2
Bufotenine	8
Cathinone	3
Codeine-N-oxide	302
Diethyltryptamine	2
Difenoxin	50
Dihydromorphine	2,549,000
Dimethyltryptamine	3
Gamma-hydroxybutyric acid	23,600,000
Heroin	5
Hydromorphinol	3,000
Hydroxypethidine	2
Ibogaine	1
Lysergic acid diethylamide (LSD)	61
Marihuana	4,500,000
Mescaline	2
Methaqualone	10
Methcathinone	4
Methyldihydromorphine	2
Morphine-N-oxide	310
N,N-Dimethylamphetamine	7
N-Ethylamphetamine	2
N-Hydroxy-3,4-methylenedioxyamphetamine	2
Noracymethadol	2
Norlevorphanol	52
Normethadone	2
Normorphine	16
Para-fluorofentanyl	2
Phenomorphan	2
Pholcodine	2
Psilocybin	7
Psilocyn	7
Tetrahydrocannabinols	312,500
Thiofentanyl	2
Trimeperidine	2

Basic class—Schedule II	Final revised 2007 quotas (grams)
1-Phenylcyclohexylamine	2
Alfentanil	5,200
Alphaprodine	2
Amobarbital	3
Amphetamine (for sale)	17,000,000
Amphetamine (for conversion)	5,000,000
Cocaine	286,000
Codeine (for sale)	39,605,000
Codeine (for conversion)	59,000,000
Dextropropoxyphene	120,000,000
Dihydrocodeine	2,435,000
Diphenoxylate	828,000
Ecgonine	83,000
Ethylmorphine	2
Fentanyl	1,428,000
Glutethimide	2
Hydrocodone (for sale)	46,000,000
Hydrocodone (for conversion)	1,500,000
Hydromorphone	3,300,000
Isomethadone	2
Levo-alphacetylmethadol (LAAM)	6
Levomethorphan	5
Levorphanol	6,000
Lisdexamfetamine	6,200,000
Meperidine	9,753,000
Metazocine	1
Methadone (for sale)	25,000,000
Methadone Intermediate	26,000,000
Methamphetamine	3,130,000
Methylphenidate	50,000,000
Morphine (for sale)	35,000,000
Morphine (for conversion)	110,774,000
Nabilone	3,002
Noroxymorphone (for sale)	1,002
Noroxymorphone (for conversion)	11,000,000
Opium	1,400,000
Oxycodone (for sale)	70,000,000
Oxycodone (for conversion)	3,100,000
Oxymorphone	1,800,000
Oxymorphone (for conversion)	15,300,000
Pentobarbital	35,200,000
Phencyclidine	2,021
Phenmetrazine	2
Racemethorphan	2
Remifentanil	3,000
Secobarbital	2
Sufentanil	10,300
Thebaine	126,000,000

The Deputy Administrator further orders that the aggregate production quotas for all other schedules I and II controlled substances included in 21 CFR 1308.11 and 1308.12 shall be zero.

The Office of Management and Budget has determined that notices of aggregate production quotas are not subject to centralized review under Executive Order 12866.

This action does not preempt or modify any provision of state law; nor does it impose enforcement responsibilities on any state; nor does it diminish the power of any state to enforce its own laws. Accordingly, this action does not have federalism implications warranting the application of Executive Order 13132.

The Deputy Administrator hereby certifies that this action will have no significant impact upon small entities whose interests must be considered under the Regulatory Flexibility Act, 5 U.S.C. 601 et seq. The establishment of aggregate production quotas for schedules I and II controlled substances is mandated by law and by international treaty obligations. The quotas are necessary to provide for the estimated medical, scientific, research and industrial needs of the United States, for export requirements and the establishment and maintenance of reserve stocks. While aggregate production quotas are of primary importance to large manufacturers, their impact upon small entities is neither negative nor beneficial. Accordingly, the Deputy Administrator has determined that this action does not require a regulatory flexibility analysis.

This action meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform.

This action will not result in the expenditure by state, local, and tribal governments, in the aggregate or by the private sector, of $120,000,000 or more in any one year, and will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

This action is not a major rule as defined by section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996. This action will not result in an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets.

Dated: August 15, 2007.

Michele M. Leonhart,

Deputy Administrator.